ANDA 74926, held by Cosette Pharms Nc. Miconazole Nitrate.
As of Nov 15, 2026, ANDA 74926 (M-Zole 3 Combination Pack), held by Cosette Pharms Nc, was first approved by FDA on Apr 16, 1999, with 7 approved supplements and 0 published complete response letters.
Uses treats vaginal yeast infections relieves external itching and irritation due to a vaginal yeast infection
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 16, 1999 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| M-Zole 3 Combination Pack2%,200MG · cream, suppository;topical, vaginal | Miconazole Nitrate | OTC |
| Jun 19, 2018 | Supplement 18Labeling · Standard review | Approved | None posted |
| Apr 8, 2005 | Supplement 8Labeling | Approved | None posted |
| Aug 14, 2003 | Supplement 6Labeling | Approved | None posted |
| Nov 21, 2002 | Supplement 4Labeling | Approved | None posted |
| Mar 15, 2002 | Supplement 3Manufacturing | Approved | None posted |
| Dec 4, 2001 | Supplement 2Manufacturing | Approved | None posted |
| Dec 29, 2000 | Supplement 1Manufacturing | Approved | None posted |
| Apr 16, 1999 | Original application | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
